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EC number: 201-186-8 | CAS number: 79-21-0
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- no
- Remarks:
- (GLP was not mandatory at the time of study conduct.)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Peracetic acid
- EC Number:
- 201-186-8
- EC Name:
- Peracetic acid
- Cas Number:
- 79-21-0
- Molecular formula:
- C2H4O3
- IUPAC Name:
- Peracetic acid generated by perhydrolysis of N-acetylcaprolactam by hydrogen peroxide in alkaline conditions
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254
- Test concentrations with justification for top dose:
- 1st series of tests: 4576, 915, 183, 36, 7 µg P3 Oxonia Active/plate (206, 41, 8.2, 1.6 µg peracetic acid/plate)
2nd series of tests: 915, 457, 228, 114, 57 µg P3 Oxonia Active/plate (41, 10, 5.1, 2.6 µg peracetic acid/plate)
Controls
- Untreated negative controls:
- yes
- Remarks:
- (distilled water and untreated cell suspensions)
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: (without S9 mix: sodium azide for strains TA 1535 and TA 100; 9-aminoacridin for strain TA 1537; 4-nitro-o-phenylendiamin for strains TA 1538 and TA 98; t-butylhydroperoxide for strain TA 102. With S9 mix: 2-aminoanthracen)
- Details on test system and experimental conditions:
- - Source of tester strains: American Type Culture Collection, Rockville, Maryland
- Way of application : Test substance was diluted in water. In test tubes, agar, bacterial suspension and test substance solution was added. The agar was supplemented with a histidin/biotin solution (0.5 mM) prior to experiment. Finally, either S9 mix or the according amount of water were added. The suspension was then spread on minimal agar dishes.
- Number of replicates: two independent experiments
- Examinations: Number of bacterial colonies was automatically counted. Each value was measured in triplicate.
- Incubation time: 48 hours
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Remarks:
- not tested
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (at highest concentrations tested)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (at highest concentrations tested)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (at highest concentrations tested)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (at highest concentrations tested)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (at highest concentrations tested)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (at highest concentrations tested)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- see Tables 1-2 for details
Any other information on results incl. tables
Table 1: Reverse mutation assay with P3 oxonia aktiv in bacteria: Mean number of revertants/plate both in the presence and absence of S9 mix - 1st trial
S 9 mix |
Test substance concentration |
Number of revertants (number of colonies/plate) |
|||||
TA 1535 |
TA 100 |
TA 102 |
TA 1537 |
TA 1538 |
TA 98 |
||
- |
Solvent control |
7.8 |
66.6 |
175.6 |
7.0 |
12.6 |
17.3 |
- |
7 |
8.6 |
65.0 |
206.0 |
6.0 |
12.0 |
25.0 |
- |
36 |
9.3 |
90.3 |
191.6 |
6.6 |
11.3 |
28.0 |
- |
183 |
11.6 |
65.6 |
231.0 |
4.0 |
7.0 |
9.0 |
- |
915 |
-a |
-a |
-a |
-a |
-a |
-a |
- |
4576 |
-a |
-a |
-a |
-a |
-a |
-a |
Positive control |
Name |
Natriumazid |
Natriumazid |
t-Butyl-hydro-peroxid |
9-Amino-acridin |
4-Nitro-o-phenylen-diamin |
4-Nitro-o-phenylen-diamin |
Concentration (µg/plate) |
2 |
2 |
100 |
80 |
40 |
40 |
|
Number of colonies/plate |
213.6 |
326.0 |
1338.6 |
241.3 |
776.6 |
598.3 |
|
Name |
2-Amino-anthrazen |
2-Amino-anthrazen |
2-Amino-anthrazen |
2-Amino-anthrazen |
2-Amino-anthrazen |
2-Amino-anthrazen |
|
Concentration (µg/plate) |
5 |
5 |
5 |
5 |
5 |
5 |
|
Number of colonies/plate |
7.3 |
68.0 |
178.3 |
8.6 |
14.6 |
20.3 |
|
+ |
Solvent control |
13.5 |
104.3 |
347.5 |
12.6 |
29.6 |
37.6 |
+ |
7 |
11.3 |
120.6 |
406.3 |
12.6 |
34.0 |
43.6 |
+ |
36 |
13.0 |
128.3 |
414.0 |
13.3 |
26.3 |
33.0 |
+ |
183 |
14.0 |
167.6 |
520.6 |
12.6 |
30.0 |
21.3 |
+ |
915 |
-a |
78.6 |
-a |
-a |
17.6 |
26.3 |
+ |
4576 |
-a |
-a |
-a |
-a |
-a |
-a |
Positive control |
Name |
Natriumazid |
Natriumazid |
t-Butyl-hydro-peroxid |
9-Amino-acridin |
4-Nitro-o-phenylen-diamin |
4-Nitro-o-phenylen-diamin |
Concentration (µg/plate) |
2 |
2 |
100 |
80 |
40 |
40 |
|
Number of colonies/plate |
615.0 |
610.6 |
1441.6 |
408.3 |
976.3 |
716.3 |
|
Name |
2-Amino-anthrazen |
2-Amino-anthrazen |
2-Amino-anthrazen |
2-Amino-anthrazen |
2-Amino-anthrazen |
2-Amino-anthrazen |
|
Concentration (µg/plate) |
5 |
5 |
5 |
5 |
5 |
5 |
|
Number of colonies/plate |
91.6 |
2417.6 |
1269.0 |
129.3 |
2191.3 |
2194.6 |
|
-a: complete bacterial growth inhibition
Table 2: Reverse mutation assay with P3 oxonia aktiv in bacteria: Mean number of revertants/plate both in the presence and absence of S9 mix - 2nd tri
S 9 mix |
Test substance concentration |
Number of revertants (number of colonies/plate) |
|||||
TA 1535 |
TA 100 |
TA 102 |
TA 1537 |
TA 1538 |
TA 98 |
||
- |
Solvent control |
10.0 |
84.1 |
208.6 |
7.1 |
16.5 |
22.1 |
- |
57 |
10.3 |
132.0 |
272.0 |
7.3 |
15.3 |
15.3 |
- |
114 |
8.0 |
138.6 |
209.0 |
6.6 |
13.3 |
18.0 |
- |
228 |
-a |
101.0 |
165.6 |
5.0 |
-a |
-a |
- |
457 |
-a |
-a |
157.0 |
-a |
-a |
-a |
- |
9156 |
-a |
-a |
-a |
-a |
-a |
-a |
Positive control |
Name |
Natriumazid |
Natriumazid |
t-Butyl-hydro-peroxid |
9-Amino-acridin |
4-Nitro-o-phenylen-diamin |
4-Nitro-o-phenylen-diamin |
Concentration (µg/plate) |
2 |
2 |
100 |
80 |
40 |
40 |
|
Number of colonies/plate |
167.3 |
412.0 |
750.0 |
359.6 |
1009.0 |
606.0 |
|
Name |
2-Amino-anthrazen |
2-Amino-anthrazen |
2-Amino-anthrazen |
2-Amino-anthrazen |
2-Amino-anthrazen |
2-Amino-anthrazen |
|
Concentration (µg/plate) |
5 |
5 |
5 |
5 |
5 |
5 |
|
Number of colonies/plate |
12.3 |
100.0 |
203.6 |
8.0 |
17.6 |
29.0 |
|
+ |
Solvent control |
12.0 |
107.6 |
452.1 |
12.1 |
24.1 |
49.1 |
+ |
57 |
17.6 |
135.3 |
390.0 |
12.0 |
25.6 |
56.6 |
+ |
114 |
11.0 |
170.6 |
412.3 |
12.6 |
22.0 |
61.0 |
+ |
228 |
8.3 |
173.0 |
462.3 |
8.3 |
24.3 |
41.6 |
+ |
457 |
-a |
131.0 |
466.3 |
7.0 |
23.3 |
-a |
+ |
9156 |
-a |
-a |
311.0 |
-a |
-a |
-a |
Positive control |
Name |
Natriumazid |
Natriumazid |
t-Butyl-hydro-peroxid |
9-Amino-acridin |
4-Nitro-o-phenylen-diamin |
4-Nitro-o-phenylen-diamin |
Concentration (µg/plate) |
2 |
2 |
100 |
80 |
40 |
40 |
|
Number of colonies/plate |
74.0 |
440.0 |
821.6 |
275.3 |
823.0 |
463.0 |
|
Name |
2-Amino-anthrazen |
2-Amino-anthrazen |
2-Amino-anthrazen |
2-Amino-anthrazen |
2-Amino-anthrazen |
2-Amino-anthrazen |
|
Concentration (µg/plate) |
5 |
5 |
5 |
5 |
5 |
5 |
|
Number of colonies/plate |
81.6 |
1896.0 |
1040.6 |
141.3 |
1493.0 |
1882.6 |
|
-a: complete bacterial growth inhibition
Applicant's summary and conclusion
- Conclusions:
- negative without metabolic activation
negative with metabolic activation - Executive summary:
P3 oxonia aktiv (4.6 % peracetic acid, 29.4 % hydrogen peroxide, 7.4 % acetic acid) was tested for its in vitro mutagenicity in an bacterial reverse mutation test (Ames-test). 5 different concentrations of the test material were applied to 6 different strains of Salmonella typhimurium (TA 1535, TA 100, TA 102, TA 1537, TA 1538 and TA 98) in two independent experimental series. The tests were performed on agar plates in the absence or presence of post-mitochondrial supernatant fluids from the liver of male rats treated with Aroclor 1254 (S9-mix).
P3 oxonia aktiv did not induce reverse mutations in the presence or absence of S9-mix in the tested strains of Salmonella typhimurium.
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